Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 546 for:    "Skin cancer"

Experience of Non-Melanoma Skin Cancer (NMSC) Mohs Surgery Project

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01452984
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : March 19, 2015
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Tracking Information
First Submitted Date October 13, 2011
First Posted Date October 17, 2011
Last Update Posted Date March 19, 2015
Study Start Date July 2011
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 18, 2015)
Number of Adverse Events
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01452984 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Experience of Non-Melanoma Skin Cancer (NMSC) Mohs Surgery Project
Official Title Experience of Patients With Non-Melanoma Skin Cancer of the Head and Neck Undergoing Mohs Surgery
Brief Summary Mohs surgery excises non-melanoma skin cancer tumors of the head and neck while preserving maximum healthy tissue, an advantageous characteristic when dealing with the cosmetic and functional cervifacial region. Yet, treatment can result in changes to function and appearance with effects on quality of life. This project uses Grounded Theory to explore the Mohs surgery experience of NMSC patients who have head and neck lesions through interview and observation of the surgical appointment.
Detailed Description Mohs surgery offers significant benefits in excising NMSC tumors of the head and neck by precisely removing cancerous tissue while preserving the maximum amount of healthy tissue, a characteristic of particular advantage when dealing with NMSC in the highly cosmetic and functional cericofacial region. Despite this, few studies have explored the patient perspective on their experience with Mohs surgery. Futhermore, treatment for NMSC can result in scarring, disfigurement, and changes to function and appearance. Ramifications on identity and self, embodiment and aesthetics, interaction and relationships appear likely and consequences on function and quality of life might then follow. Using Grounded Theory, this project aims to explore the question "what is the experience of Mohs surgery for non-melanoma skin cancer patients who have lesions of the head and neck?" Potential patient participants are those diagnosed with non-melanoma skin cancer, who have undergone Mohs surgery or are scheduled to undergo Mohs surgery on skin located in any area above the shoulders, and are referred to the project by their surgeons. They will represent a range of disease, from those who have had a single Mohs surgery to those with recurrent NMSC and repeated Mohs. Patients will also read and speak English and be at least 18 years of age. Transcribed interviews and field notes will be analyzed using constant comparative technique to develop descriptive and theoretical understandings of how experience Mohs surgery for non-melanoma skin cancer of the head and nexk.
Study Type Observational
Study Design Observational Model: Cohort
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This study involves non-melanoma skin cancer patients who have undergone or are about to undergo Mohs surgery, who are treated within the University of Pennsylvania Health System.
Condition Non-Melanoma Skin Cancer
Intervention Not Provided
Study Groups/Cohorts
  • Single Retrospective Interviews
    Each retrospective interview will be conducted by the Principal Investigator and/or Project Manager to collect denmographic information and experiential narratives from the patient, using open-ended questions and structured probes based on individual responses. Retrospective interviews will be recorded and scheduled at the patients' convenience either in the clinic, at the home, or at a place that is convenient to them.
  • Prospective Observations
    Prospective Observations of clinic visits will be combined with informal interview to document conversations with their treating physicians about concerns emerging from appearance, function, and other factors that may impinge on clinical decision making and experience including quality of life. The Project Manager will be present for the clinical visit during which the Mohs surgery takes place and record field observations as well as informal interview notes in a notebook.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 18, 2015)
16
Original Estimated Enrollment
 (submitted: October 14, 2011)
40
Actual Study Completion Date December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient participants must have an upcoming Mohs surgery scheduled or have already undergone Mohs surgery within the University of Pennsylvania Health System.
  • All participants must read and speak English.
  • For those patient participants with communication impairments due to surgery and treatment, accomodations for alternate methods of communication, including typing responses to the interview guide into a laptop computer or writing responses with a pen on paper, will be provided.
  • Both male and female
  • Must read and speak English
  • Be over the age 18 and able to give consent.

Exclusion Criteria:

  • This study excludes patients and their partners who are incapacitated or not old enough to give consent, more specifically those under the age of 18.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01452984
Other Study ID Numbers UPCC 07311
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Abramson Cancer Center of the University of Pennsylvania
Study Sponsor Abramson Cancer Center of the University of Pennsylvania
Collaborators Not Provided
Investigators
Principal Investigator: Sarah Kagan, PhD, RN Abramson Cancer Center of the University of Pennsylvania
PRS Account Abramson Cancer Center of the University of Pennsylvania
Verification Date March 2015